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Desvenlafaxine, a serotonin and norepinephrine reuptake inhibitor (SNRI), is indicated for the treatment of major depressive disorder (MDD) [see Clinical Studies (14) and Dosage and Administration (2.1)]. The efficacy of desvenlafaxine has been established in four short-term (8-week, placebo-controlled studies) of outpatients who met DSM-IV criteria for major depressive disorder.
There is currently no drug history available for this drug.
Desvenlafaxine is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder.
Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C16H25NO2 (free base) and C16H25NO2•C4H6O4•H2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below.
Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7) partition coefficient is 0.21.
Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration.
Each tablet contains 76 mg or 152 mg of desvenlafaxine succinate equivalent to 50 mg or 100 mg of desvenlafaxine, respectively.
Inactive ingredients for the 50 mg tablet consist of hypromellose, magnesium stearate, microcrystalline cellulose, povidone, talc and film coating, which consists of hypromellose, iron oxide red, polyethylene glycol, talc, and titanium dioxide.
Inactive ingredients for the 100 mg tablet consist of hypromellose, magnesium stearate, microcrystalline cellulose, povidone, talc and film coating, which consists of hypromellose, iron oxide black, iron oxide red, polyethylene glycol, talc, and titanium dioxide.